The Use of Magnetic Brain Stimulation to Treat Obsessive Compulsive Disorder, a Pilot Study

NCT ID: NCT02541812

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-06-30

Brief Summary

The purpose of this study is two-fold: first, to observe the effect of one session of repetitive transcranial magnetic stimulation (rTMS) on the error-prediction abilities of patients with obsessive compulsive disorder (OCD) as well as healthy individuals; and second, to observe the clinical effect of 10 sessions of rTMS in patients with OCD.

Detailed Description

A battery of cognitive tasks designed to selectively measure several aspects of anterior cingulate cortex (ACC) function, will be administered before and after one session of rTMS in all participants. The first neurocognitive session will be administered in a separate day from the rTMS session. The second neurocognitive session will be performed immediately after rTMS and in the same day. Participants will perform five tasks designed to test: error processing, error likelihood assessment, meta-memory, response inhibition, and affect recognition.

The rTMS paradigm will consist of four short trains of magnetic pulses which include 5 minutes of stimulation with 1Hz frequency (overall 1200 pulses in one session) with an intensity of 110% of each participant's motor threshold, and 2 minute intervals between the stimulation trains. Stimulation will be applied over the dorsal ACC (dACC) using a double-cone rTMS coil. dACC will be precisely targeted using neuronavigation software loaded a high resolution MRI of each subjects' brain.

OCD patients will go on to receive two weeks (10 sessions) of daily rTMS treatments using the same protocol described above.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients

Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

A non-invasive method for brain stimulation

Healthy Control Subjects

One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

A non-invasive method for brain stimulation

Interventions

Transcranial Magnetic Stimulation

A non-invasive method for brain stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosed obsessive compulsive disorder
• Not currently receiving cognitive behavioural therapy
• Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI)

Exclusion Criteria

• History of psychotic episodes
• History of neurological illness
• Previous head injury
• Active alcohol or substance abuse
• History of seizure disorders
• Currently pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mandana Modirrousta, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

References

Modirrousta M, Meek BP, Sareen J, Enns MW. Impaired trial-by-trial adjustment of cognitive control in obsessive compulsive disorder improves after deep repetitive transcranial magnetic stimulation. BMC Neurosci. 2015 Oct 9;16:63. doi: 10.1186/s12868-015-0205-z.

Reference Type: DERIVED

PMID: 26453446 (View on PubMed)

Other Identifiers

B2009:077

Identifier Type: -

Identifier Source: org_study_id